Pfizer's C. diff vaccine gains on Sanofi with FDA fast-track nod
Look out, Sanofi. Pfizer's Clostridium difficile candidate has just nabbed an FDA fast-track designation that should help it pick up some ground in the race to bring the first vaccine for the disease to market.
Thursday, the FDA announced it would help accelerate the development and review process for Pfizer's ($PFE) Phase II vaccine, which is intended to help prevent the approximately 14,000 deaths per year that occur in the U.S. on account of C. diff-associated disease.
"C. difficile is a growing, difficult-to-treat healthcare-associated infection," Dr. Emilio Emini, Pfizer's SVP of Vaccine R&D, said in a statement.
|Dr. Emilio Emini, Pfizer's SVP of vaccine R&D|
While there's currently no vaccine out there to prevent the gut disease--which most commonly affects older adults in hospitals or in long-term care facilities and typically occurs after antibiotics use--Pfizer's candidate is not alone in the clinic. Right now, Sanofi's ($SNY) Phase III jab leads Pfizer and French biotech Valneva, which says it expects to initiate Phase II studies by the end of this year.
And there's an expanding market out there waiting for whichever company gets there first, analysts figure. In November 2012, Morningstar analyst David Krempa estimated the market for C. diff medicines and vaccines could swell to $2 billion a year--10 times its size at the time.
The C. diff candidate is not Pfizer's only one to win a little speed from the FDA as of late. In June, the agency awarded Pfizer's meningitis B candidate, rLP2086, with its breakthrough therapy designation; that jab has a PDUFA date set for next February.
- read Pfizer's release
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